ORIGINAL ARTICLE
European Journal of Cardio-Thoracic Surgery 47 (2015) 1083–1089 doi:10.1093/ejcts/ezu339 Advance Access publication 12 September 2014
Cite this article as: Penkalla A, Pasic M, Drews T, Buz S, Dreysse S, Kukucka M et al. Transcatheter aortic valve implantation combined with elective coronary artery stenting: a simultaneous approach. Eur J Cardiothorac Surg 2015;47:1083–9.
Transcatheter aortic valve implantation combined with elective coronary artery stenting: a simultaneous approach† Adam Penkalla, Miralem Pasic*, Thorsten Drews, Semih Buz, Stephan Dreysse, Marian Kukucka, Alexander Mladenow, Roland Hetzer and Axel Unbehaun Deutsches Herzzentrum Berlin, Berlin, Germany * Corresponding author: Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353 Berlin, Germany. Tel: +49-30-45932108; fax: +49-30-45932018; e-mail: [email protected] (M. Pasic). Received 16 December 2013; received in revised form 23 July 2014; accepted 1 August 2014
Abstract OBJECTIVES: Many patients referred for transcatheter aortic valve implantation (TAVI) also require percutaneous coronary intervention (PCI). The aim of the study was to identify whether combined treatment of patients with aortic stenosis and coronary artery disease (CAD) with TAVI and PCI has comparable results to treatment of patients with no CAD or with CAD with non-significant lesions who receive only TAVI. METHODS: Between April 2008 and August 2013, 730 consecutive patients underwent transapical TAVI at our institution. In our study population of 593 patients, 285 (48.1%) had no CAD and received TAVI only (Group I); 232 (39.1%) presented with CAD but no highly significant coronary artery lesion(s) and also received TAVI only (Group II), and 76 (12.8%) had CAD and highly significant coronary lesion(s) and underwent combined, single-staged TAVI and PCI (Group III). Three transapical TAVI patients who received PCI because of iatrogenic coronary artery obstruction during TAVI and 134 transapical TAVI patients with previous CABG were excluded from this study.
CONCLUSIONS: Single-stage combined treatment of severe aortic stenosis and highly relevant coronary lesions is a safe and feasible procedure. Early survival and survival up to 3 years are comparable to that observed in patients presenting without CAD who received TAVI only. PCI effectively reduces the complexity of coronary lesions. Although more contrast agent is applied during the combined treatment, the rate of acute kidney injury was not higher. Keywords: Aortic valve stenosis • Transcatheter aortic valve implantation • Coronary artery disease • Percutaneous coronary intervention
INTRODUCTION About two thirds of patients referred for transcatheter aortic valve implantation (TAVI) present with concomitant coronary artery disease (CAD) [1, 2]. Several studies have already attempted to answer the question of whether TAVI and percutaneous coronary intervention (PCI), performed either in a staged [3–5] or combined [1, 5] † Presented at the 27th Annual Meeting of the European Association for CardioThoracic Surgery, Vienna, Austria, 5–9 October 2013.
fashion, is a feasible and safe procedure. It is not clear how CAD can be optimally treated in patients undergoing TAVI. Almost from the introduction of TAVI at our institution, we adopted a strategy to treat it simultaneously [1]. To prevent postoperative myocardial infarction, only highly significant lesions were treated. The aim of the present study was to investigate our results in a larger group of patients and to establish whether the preliminary results were maintained during the following experience. In particular, we analysed the impact of the SYNTAX score on our results [6].
© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
ADULT CARDIAC
RESULTS: Group II showed a calculated mean SYNTAX score of 5.7 ± 7.4. However, Group III showed a statistically significantly higher mean SYNTAX score of 8.0 ± 5.7 than Group II (P < 0.001) before the combined procedure. Combined TAVI and PCI reduced the mean SYNTAX score significantly from 8.0 ± 5.7 to 3.0 ± 4.9 (P < 0.001) in those patients presenting with severe aortic stenosis and highly significant CAD (Group III). The thirty-day all-cause mortality rate was 5.3, 3.9 and 2.6% for Group I, II and III, respectively (P = 0.609). Patients with highly significant CAD undergoing TAVI and PCI had similar survival up to 3 years as patients without CAD undergoing TAVI only. Radiation time and amount of contrast agent were higher during combined treatment in Group III (P < 0.05). However, no difference in acute kidney injury post-procedurally was observed.
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A. Penkalla et al. / European Journal of Cardio-Thoracic Surgery
PATIENTS AND METHODS Patients From April 2008 through August 2013, transapical TAVI was performed in 730 consecutive patients with severe aortic valve stenosis at our institution. Only patients undergoing transapical TAVI were considered in this study. Three transapical TAVI patients requiring PCI because of iatrogenic coronary artery obstruction during TAVI were excluded from this study. Owing to difficulties with comparability and the calculation of an angiographic risk score, 134 transapical TAVI patients with previous CABG were also excluded. In the resulting study population of 593 patients, 285 (48.1%) had no CAD and received TAVI only (Group I); 232 (39.1%) presented with CAD but no highly significant coronary artery lesion(s) as defined previously [1] and received TAVI only (Group II). Seventy-six (12.8%) patients presented with CAD and highly significant coronary lesion(s) and underwent combined single-staged TAVI and PCI (Group III). Written informed consent was obtained from all patients or their representatives. Our institutional review board approved the study.
Methods Our TAVI team consists of five cardiac surgeons, two cardiologists and two anaesthesiologists with expertise in echocardiography. A perfusionist was present and a heart–lung machine was on standby in the hybrid operating room (OR). Transapical TAVI was performed through a left anterior minithoracotomy using balloonexpandable transcatheter stent-prosthetic xenograft valves of 23, 26 and 29 mm diameter with their delivering systems (Edwards SAPIEN THV, Edwards Lifesciences, Irvine, CA, USA). TAVI was performed as originally described, with some modifications [7, 8]. Clinical and anatomical selection criteria and device size selection have been described elsewhere [9]. The procedure was monitored by fluoroscopy, angiography and continuous intraoperative transoesophageal echocardiography (TOE). TAVI was always done before PCI. PCI was routinely performed via transfemoral access and the femoral artery puncture site was subsequently closed using the Proglide vascular closure device (Abbott Vascular, Abbott Park, IL, USA). Standard catheters, guidewires and stents from several manufacturers were used as for a standard PCI at our institution. The contrast agent iopromide (ULTRAVIST®-370, Bayer AG, Leverkusen, Germany) was used for angiography. All procedures were performed under general anaesthesia in the hybrid OR with a monoplane angiography system (Siemens Artis ZEE, Siemens AG, Munich, Germany).
Principles of percutaneous coronary intervention during a combined procedure at our institution The most important issue in this study was the definition of what counts as highly significant CAD. Our approach originates from a tried and tested surgical strategy that has been developed over the past 20 years in the treatment of octogenarians with severe aortic valve stenosis and CAD [1, 10]. Coronary artery bypass grafting was only performed on relevant coronary artery lesions to
keep the aortic cross-clamp time and operative time as short as possible. Our criteria for simultaneous PCI and TAVI were [1] as follows: (i) left main coronary artery stenosis if >50%; (ii) coronary stenosis of 90% or more in the proximal or mid-left anterior descending (LAD) or (iii) coronary stenosis of 90% or more in the proximal or midright coronary artery (if dominant artery) or (iv) coronary stenosis of 90% or more in the proximal or mid-left circumflex artery (if dominant). Our strategy of combined TAVI and PCI was not aimed at the treatment of CAD in general but was designed to prevent postoperative complications without increasing the risks of the procedure. The advantage of simultaneous TAVI and PCI is the prevention of post-procedural myocardial infarction. Both pathologies—aortic stenosis and CAD—are treated at the same time and hence there is no need for further interventions [1]. Coronary artery stenosis was regarded as highly significant only if the diseased artery vascularized a large myocardial territory and the stenosis put a large myocardial area at risk [1]. The coronary lesion should be technically amenable to straightforward PCI [1] and PCI should be able to be performed with a very high probability of success [1]. Exceptionally, a complex PCI combined with TAVI was accepted but only in patients for whom conventional surgery was considered not to be suitable [1].
Follow-up The follow-up regarding death or survival was 100%. We obtained official information regarding death from the state administrative office. Information for all patients living in Germany was obtained from the German Register of Residents. All patients living in foreign countries were contacted via telephone, email or letter. The date of the last contact was noted.
Post-procedural anticoagulation and antiplatelet therapy Our institutional anticoagulation protocol was applied peri- and postoperatively. We do not preload patients with antiplatelet therapy before the combined procedure. However, some of our patients had been treated with aspirin or double antiplatelet therapy by their cardiologists before TAVI. Intraoperatively, 100 IU/kg heparin was given and controlled by activated clotting time. If no bleeding tendency was seen at the end of TAVI procedure, we did not antagonize heparin with protamine routinely. Postoperatively, heparin was continued intravenously in all patients until good mobilization was reached. The dose was maintained according to the activated partial thromboplastin time (50–60 s). After combined TAVI and PCI, our antiplatelet strategy consists of 600 mg clopidogrel and 100 mg aspirin given once as a loading dose after the procedure at the ICU, 75 mg clopidogrel per day for 6 months for bare-metal stents and for 12 months for drug-eluting stents and, additionally, 100 mg aspirin per day permanently. Antiplatelet therapy for patients undergoing only TAVI is 75 mg clopidogrel per day for 6 months and 100 mg aspirin per day permanently from the first postoperative day.
A. Penkalla et al. / European Journal of Cardio-Thoracic Surgery
SYNTAX score calculation For this study, all coronary angiography and SYNTAX scores were calculated and analysed retrospectively by one observer using SYNTAX Score Calculator version 2.11. A small number of SYNTAX scores in our database were calculated prospectively; these scores were recalculated and checked by one observer retrospectively. The SYNTAX score for patients without CAD was set at zero. The score for patients with CAD but no highly significant coronary lesion(s) was calculated and analysed retrospectively. Pre- and post-procedural SYNTAX scores for 76 patients having received combined TAVI and PCI were calculated and analysed retrospectively. For calculation of the post-procedural SYNTAX score, the lesion score for a successfully stented lesion site was set at zero.
1085
Multivariable regression methods were used to evaluate the differences between groups for the following variables: SYNTAX score, radiation time, contrast agent, 30-day mortality, acute kidney injury stage 1 and 3 and periprocedural and spontaneous myocardial infarction. Variables were adjusted for age, gender, logistic EuroSCORE and previous pacemaker/implantable cardioverter-defibrillator implantation. Under the results section, we present only data for group differences and not for the adjusting variables. Analysis of survival was calculated according to Kaplan–Meier estimation and compared using the log-rank test. A P-value of
European Journal of Cardio-Thoracic Surgery 47 (2015) 1083–1089 doi:10.1093/ejcts/ezu339 Advance Access publication 12 September 2014
Cite this article as: Penkalla A, Pasic M, Drews T, Buz S, Dreysse S, Kukucka M et al. Transcatheter aortic valve implantation combined with elective coronary artery stenting: a simultaneous approach. Eur J Cardiothorac Surg 2015;47:1083–9.
Transcatheter aortic valve implantation combined with elective coronary artery stenting: a simultaneous approach† Adam Penkalla, Miralem Pasic*, Thorsten Drews, Semih Buz, Stephan Dreysse, Marian Kukucka, Alexander Mladenow, Roland Hetzer and Axel Unbehaun Deutsches Herzzentrum Berlin, Berlin, Germany * Corresponding author: Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353 Berlin, Germany. Tel: +49-30-45932108; fax: +49-30-45932018; e-mail: [email protected] (M. Pasic). Received 16 December 2013; received in revised form 23 July 2014; accepted 1 August 2014
Abstract OBJECTIVES: Many patients referred for transcatheter aortic valve implantation (TAVI) also require percutaneous coronary intervention (PCI). The aim of the study was to identify whether combined treatment of patients with aortic stenosis and coronary artery disease (CAD) with TAVI and PCI has comparable results to treatment of patients with no CAD or with CAD with non-significant lesions who receive only TAVI. METHODS: Between April 2008 and August 2013, 730 consecutive patients underwent transapical TAVI at our institution. In our study population of 593 patients, 285 (48.1%) had no CAD and received TAVI only (Group I); 232 (39.1%) presented with CAD but no highly significant coronary artery lesion(s) and also received TAVI only (Group II), and 76 (12.8%) had CAD and highly significant coronary lesion(s) and underwent combined, single-staged TAVI and PCI (Group III). Three transapical TAVI patients who received PCI because of iatrogenic coronary artery obstruction during TAVI and 134 transapical TAVI patients with previous CABG were excluded from this study.
CONCLUSIONS: Single-stage combined treatment of severe aortic stenosis and highly relevant coronary lesions is a safe and feasible procedure. Early survival and survival up to 3 years are comparable to that observed in patients presenting without CAD who received TAVI only. PCI effectively reduces the complexity of coronary lesions. Although more contrast agent is applied during the combined treatment, the rate of acute kidney injury was not higher. Keywords: Aortic valve stenosis • Transcatheter aortic valve implantation • Coronary artery disease • Percutaneous coronary intervention
INTRODUCTION About two thirds of patients referred for transcatheter aortic valve implantation (TAVI) present with concomitant coronary artery disease (CAD) [1, 2]. Several studies have already attempted to answer the question of whether TAVI and percutaneous coronary intervention (PCI), performed either in a staged [3–5] or combined [1, 5] † Presented at the 27th Annual Meeting of the European Association for CardioThoracic Surgery, Vienna, Austria, 5–9 October 2013.
fashion, is a feasible and safe procedure. It is not clear how CAD can be optimally treated in patients undergoing TAVI. Almost from the introduction of TAVI at our institution, we adopted a strategy to treat it simultaneously [1]. To prevent postoperative myocardial infarction, only highly significant lesions were treated. The aim of the present study was to investigate our results in a larger group of patients and to establish whether the preliminary results were maintained during the following experience. In particular, we analysed the impact of the SYNTAX score on our results [6].
© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
ADULT CARDIAC
RESULTS: Group II showed a calculated mean SYNTAX score of 5.7 ± 7.4. However, Group III showed a statistically significantly higher mean SYNTAX score of 8.0 ± 5.7 than Group II (P < 0.001) before the combined procedure. Combined TAVI and PCI reduced the mean SYNTAX score significantly from 8.0 ± 5.7 to 3.0 ± 4.9 (P < 0.001) in those patients presenting with severe aortic stenosis and highly significant CAD (Group III). The thirty-day all-cause mortality rate was 5.3, 3.9 and 2.6% for Group I, II and III, respectively (P = 0.609). Patients with highly significant CAD undergoing TAVI and PCI had similar survival up to 3 years as patients without CAD undergoing TAVI only. Radiation time and amount of contrast agent were higher during combined treatment in Group III (P < 0.05). However, no difference in acute kidney injury post-procedurally was observed.
1084
A. Penkalla et al. / European Journal of Cardio-Thoracic Surgery
PATIENTS AND METHODS Patients From April 2008 through August 2013, transapical TAVI was performed in 730 consecutive patients with severe aortic valve stenosis at our institution. Only patients undergoing transapical TAVI were considered in this study. Three transapical TAVI patients requiring PCI because of iatrogenic coronary artery obstruction during TAVI were excluded from this study. Owing to difficulties with comparability and the calculation of an angiographic risk score, 134 transapical TAVI patients with previous CABG were also excluded. In the resulting study population of 593 patients, 285 (48.1%) had no CAD and received TAVI only (Group I); 232 (39.1%) presented with CAD but no highly significant coronary artery lesion(s) as defined previously [1] and received TAVI only (Group II). Seventy-six (12.8%) patients presented with CAD and highly significant coronary lesion(s) and underwent combined single-staged TAVI and PCI (Group III). Written informed consent was obtained from all patients or their representatives. Our institutional review board approved the study.
Methods Our TAVI team consists of five cardiac surgeons, two cardiologists and two anaesthesiologists with expertise in echocardiography. A perfusionist was present and a heart–lung machine was on standby in the hybrid operating room (OR). Transapical TAVI was performed through a left anterior minithoracotomy using balloonexpandable transcatheter stent-prosthetic xenograft valves of 23, 26 and 29 mm diameter with their delivering systems (Edwards SAPIEN THV, Edwards Lifesciences, Irvine, CA, USA). TAVI was performed as originally described, with some modifications [7, 8]. Clinical and anatomical selection criteria and device size selection have been described elsewhere [9]. The procedure was monitored by fluoroscopy, angiography and continuous intraoperative transoesophageal echocardiography (TOE). TAVI was always done before PCI. PCI was routinely performed via transfemoral access and the femoral artery puncture site was subsequently closed using the Proglide vascular closure device (Abbott Vascular, Abbott Park, IL, USA). Standard catheters, guidewires and stents from several manufacturers were used as for a standard PCI at our institution. The contrast agent iopromide (ULTRAVIST®-370, Bayer AG, Leverkusen, Germany) was used for angiography. All procedures were performed under general anaesthesia in the hybrid OR with a monoplane angiography system (Siemens Artis ZEE, Siemens AG, Munich, Germany).
Principles of percutaneous coronary intervention during a combined procedure at our institution The most important issue in this study was the definition of what counts as highly significant CAD. Our approach originates from a tried and tested surgical strategy that has been developed over the past 20 years in the treatment of octogenarians with severe aortic valve stenosis and CAD [1, 10]. Coronary artery bypass grafting was only performed on relevant coronary artery lesions to
keep the aortic cross-clamp time and operative time as short as possible. Our criteria for simultaneous PCI and TAVI were [1] as follows: (i) left main coronary artery stenosis if >50%; (ii) coronary stenosis of 90% or more in the proximal or mid-left anterior descending (LAD) or (iii) coronary stenosis of 90% or more in the proximal or midright coronary artery (if dominant artery) or (iv) coronary stenosis of 90% or more in the proximal or mid-left circumflex artery (if dominant). Our strategy of combined TAVI and PCI was not aimed at the treatment of CAD in general but was designed to prevent postoperative complications without increasing the risks of the procedure. The advantage of simultaneous TAVI and PCI is the prevention of post-procedural myocardial infarction. Both pathologies—aortic stenosis and CAD—are treated at the same time and hence there is no need for further interventions [1]. Coronary artery stenosis was regarded as highly significant only if the diseased artery vascularized a large myocardial territory and the stenosis put a large myocardial area at risk [1]. The coronary lesion should be technically amenable to straightforward PCI [1] and PCI should be able to be performed with a very high probability of success [1]. Exceptionally, a complex PCI combined with TAVI was accepted but only in patients for whom conventional surgery was considered not to be suitable [1].
Follow-up The follow-up regarding death or survival was 100%. We obtained official information regarding death from the state administrative office. Information for all patients living in Germany was obtained from the German Register of Residents. All patients living in foreign countries were contacted via telephone, email or letter. The date of the last contact was noted.
Post-procedural anticoagulation and antiplatelet therapy Our institutional anticoagulation protocol was applied peri- and postoperatively. We do not preload patients with antiplatelet therapy before the combined procedure. However, some of our patients had been treated with aspirin or double antiplatelet therapy by their cardiologists before TAVI. Intraoperatively, 100 IU/kg heparin was given and controlled by activated clotting time. If no bleeding tendency was seen at the end of TAVI procedure, we did not antagonize heparin with protamine routinely. Postoperatively, heparin was continued intravenously in all patients until good mobilization was reached. The dose was maintained according to the activated partial thromboplastin time (50–60 s). After combined TAVI and PCI, our antiplatelet strategy consists of 600 mg clopidogrel and 100 mg aspirin given once as a loading dose after the procedure at the ICU, 75 mg clopidogrel per day for 6 months for bare-metal stents and for 12 months for drug-eluting stents and, additionally, 100 mg aspirin per day permanently. Antiplatelet therapy for patients undergoing only TAVI is 75 mg clopidogrel per day for 6 months and 100 mg aspirin per day permanently from the first postoperative day.
A. Penkalla et al. / European Journal of Cardio-Thoracic Surgery
SYNTAX score calculation For this study, all coronary angiography and SYNTAX scores were calculated and analysed retrospectively by one observer using SYNTAX Score Calculator version 2.11. A small number of SYNTAX scores in our database were calculated prospectively; these scores were recalculated and checked by one observer retrospectively. The SYNTAX score for patients without CAD was set at zero. The score for patients with CAD but no highly significant coronary lesion(s) was calculated and analysed retrospectively. Pre- and post-procedural SYNTAX scores for 76 patients having received combined TAVI and PCI were calculated and analysed retrospectively. For calculation of the post-procedural SYNTAX score, the lesion score for a successfully stented lesion site was set at zero.
1085
Multivariable regression methods were used to evaluate the differences between groups for the following variables: SYNTAX score, radiation time, contrast agent, 30-day mortality, acute kidney injury stage 1 and 3 and periprocedural and spontaneous myocardial infarction. Variables were adjusted for age, gender, logistic EuroSCORE and previous pacemaker/implantable cardioverter-defibrillator implantation. Under the results section, we present only data for group differences and not for the adjusting variables. Analysis of survival was calculated according to Kaplan–Meier estimation and compared using the log-rank test. A P-value of
